Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the clean room.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves sterile injectable drugs contaminated with microorganisms and fungal growth, which presents a significant risk of serious injury or infection.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, has initiated a recall of all sterile human drugs distributed between November 21, 2011, and May 21, 2012. The recall involves five different products, including Hyaluronidase/Lidocaine/Bupivacaine and Hyaluronidase/Lidocaine/Epi/Bupivacaine injectables in various volumes.
The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where these sterile products were prepared. This lack of assurance of sterility poses a risk of infection to patients who receive these injections.
The affected products were distributed nationwide as well as to the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies. Patients and healthcare providers should stop using these products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- HYALURONIDASE / LIDOCAINE / BUPICAVAINE 7.1U/9.5MG/3.5MG/ML INJECTABLE 210 ML, 525 ML, 630 ML; HYALURONIDASE/LIDOCAINE/EPI/BUPIVICAINE INJECTABLE 32 ML, 64 ML (5 DIFFERENT PRODUCTS)
- Category
- Drug — Sterile Injectable
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Rx #'s: 0359947 0408187 0359947 0389777 0389777
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 100 recalled by Franck's Lab Inc., d.b.a. Franck's Compounding Lab under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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